3 дня назад
Associate Engineer, Maintenance Operations (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Engineer, Maintenance Operations (Medical Devices): Supporting equipment reliability, maintenance excellence, technician competency development, and manufacturing process optimization in a medical device operation with an accent on TPM, preventive maintenance, documentation governance, and data analysis. Focus on improving equipment effectiveness, coordinating Maintenance Academy and qualification programs, and maintaining compliance with cGMP, FDA 21 CFR 820, and ISO 13485 requirements.
Location: Gelang Patah, Johor, Malaysia
Company
develops the Omnipod wearable, waterproof diabetes management product platform.
What you will do
- Support equipment reliability, TPM implementation, maintenance excellence, and manufacturing process optimization initiatives.
- Coordinate the Maintenance Academy, technician certification, competency tracking, engineering transcripts, and workforce development programs.
- Maintain preventive maintenance standards, engineering records, maintenance documentation, qualification records, and change control documentation.
- Participate in Autonomous Maintenance, Planned Maintenance optimization, predictive maintenance, Lean Manufacturing, Six Sigma, Kaizen, and continuous improvement activities.
- Analyze maintenance and operational data, identify improvement opportunities, and support corrective actions.
- Collaborate with Production, Quality, Maintenance, and Engineering teams to improve equipment performance and operational excellence.
Requirements
- Bachelor’s degree in engineering, Life Sciences, or a related field; relevant education, training, and experience may be substituted.
- Basic proficiency with Microsoft Office and data analytics tools.
- Exposure to DOE, process development, structured problem-solving, DMAIC, Six Sigma, or Black Belt methodologies.
- Exposure to manufacturing, maintenance, reliability, TPM, or process improvement in pharmaceutical, medical device, or related industries.
- Strong analytical, communication, technical writing, planning, and interpersonal skills.
- Ability to work off shifts, including nights or weekends, for up to 10% of working time.
Culture & Benefits
- Work in a performance-driven manufacturing environment focused on improving patients’ lives through innovative technology.
- Collaborate across Production, Quality, Maintenance, and Engineering functions.
- Support a cGMP-compliant environment and operate in accordance with FDA 21 CFR 820 and ISO 13485 requirements.
- Contribute to technician capability development through the Maintenance Academy and qualification programs.
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